The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Bwm Spine System.
| Device ID | K982494 |
| 510k Number | K982494 |
| Device Name: | BWM SPINE SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-17 |
| Decision Date | 1998-09-08 |
| Summary: | summary |